Quality Packaging Associate II - 1st Shift
Sharp Packaging Solutions, part of UDG Healthcare plc
Summary
Function as lead associate responsible for verifying that all systems and processes are compliant with Work Instructions and Company requirements in order to begin and/or finish production activities within a specified room or rooms. Throughout production conduct attribute inspections, asset verifications and component delivery and removals according to the requirements outlined in the associated Batch Record or MPR.
Job description
Essential Duties and Responsibilities
- Adherence to and enforcement of GMP compliance, performing Quality inspections (equipment challenges and verification, components, bulk product, work-in-process and finished goods) related to contract packaging, reviewing documentation and verifying component attributes.
- The impact of the quality inspection process directly impacts company compliance with regulatory requirements and customer satisfaction.
- Read and understand process steps within the packaging record to ensure compliance during the packaging process.
- Assist where needed with the overall efficiency of the production within the assigned room or rooms.
- Inspect units for quality as they are packaged.
- Responsible for performing quality inspections as required per the packaging record and per AQL requirements. Inspections may include visual, functional, destructive and count checks.
- Verify the accuracy, completeness and supported documentation of the packaging requirements outlined below and ensure all are supported by the appropriate documentation within the Batch Record.
- Pre-start Equipment Room Check and Area clearance pages
- Pre-Post Production Pages
- Pre-Packaging Steps
- Equipment Verification page(s)
- Equipment / Component Startup Verification page(s)
- Challenges
- In-Process Inspections
- Quality Samples
- Reconciliation
- Check weigher Sheets
- Product/Component Transactions Waste logs
- TOR Logs as Applicable
Requirements
- Ability to read and understand complex packaging records
- Perform visual, functional, destructive, and count quality inspections
- Strong attention to detail for accurate documentation
- Maintain accurate documentation for equipment startup, in-process inspections, and waste logs
- Adherence to and enforcement of GMP compliance
Benefits
- Competitive salary
- Benefits
- Continuous learning
- Advancement opportunities
Company overview
Sharp Packaging Solutions, operating as part of UDG Healthcare plc, is a global leader in contract pharmaceutical packaging and clinical services with a heritage spanning more than 70 years. The company specializes in providing comprehensive packaging solutions and clinical trial supply services to pharmaceutical and biotechnology clients, supporting products from Phase I trials through commercial launch and lifecycle management. With a team of over 2,200 professionals, Sharp operates state-of-the-art GMP facilities across the United States, United Kingdom, Belgium, and the Netherlands. Their services encompass commercial packaging, clinical trial packaging, sterile manufacturing, serialization solutions, and clinical IRT services. As a division of UDG Healthcare, Sharp leverages global reach and extensive industry expertise to deliver reliable, compliant packaging solutions that ensure patient safety and product integrity throughout the pharmaceutical supply chain.